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This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.
4.1.1 Inclusion Criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
4.1.2 Exclusion Criteria
A patient who meets any of the following criteria will be excluded from the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone ophthalmic insert 0.4 mg | Experimental | Dexamethasone ophthalmic insert 0.4 mg |
|
| Topical prednisolone acetate ophthalmic drops | Active Comparator | topical prednisolone acetate ophthalmic drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone ophthalmic insert 0.4 mg | Drug | intracanalicular dexamethasone insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pain | post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine) | Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lines Lost From Best Corrected Visual Acuity | After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Wiley, MD | Cleveland Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
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Twenty-three patients were enrolled in the study. One patient failed screening and was not randomized. Two additional patients were randomized, but the Dextenza insert could not be successfully placed in the assigned eye at the time of surgery.
This prospective, randomized, fellow-eye controlled study was conducted at a single site (Clear Choice Custom LASIK Center) in 20 patients (40 eyes) with three surgeons between June 2020 and June 2021 and was performed according to guidelines established by the Declaration of Helsinki.
| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Ophthalmic Insert 0.4 mg | Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert |
| FG001 | Topical Prednisolone Acetate Ophthalmic Drops | Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Enrolled patients who underwent SMILE surgery in both eyes with investigational treatment in one eye and standard of care treatment in the fellow eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Pain | post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine) | All subjects were seen through week 1; three were lost to follow up thereafter. | Posted | Mean | Standard Deviation | Score on a scale from 0-10 | Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90 | Eyes | Eyes |
|
Baseline to 90 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone Ophthalmic Insert 0.4 mg | Dexamethasone ophthalmic insert 0.4 mg Dexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure elevation | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Jee, MD | Cleveland Eye Clinic | 440-526-1974 | kjee@midwestvision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2020 | Jun 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2022 | Jul 10, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE
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| Topical Prednisolone Acetate Ophthalmic Drops | Drug | Topical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue |
|
|
| Baseline through Day 90 |
| Loss of Lines in Uncorrected Visual Acuity | All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. | Baseline to Day 7, Day 30 and Day 90 |
| Post op Pain Management Per Eye | Count of participants requiring pain management from Day 0 to Day 90. | Day 0 to Day 90 |
| Patient Preference Between Groups | As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. | Day 7, Day 30 and Day 90 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Lines Lost From Best Corrected Visual Acuity | After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 | All subjects were seen through week 1; three were lost to follow up thereafter. | Posted | Mean | Full Range | Score on a scale | Baseline through Day 90 | Eyes | Eyes |
|
|
|
| Secondary | Loss of Lines in Uncorrected Visual Acuity | All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. | All subjects were seen through week 1; three were lost to follow up thereafter. | Posted | Mean | Standard Deviation | logMAR | Baseline to Day 7, Day 30 and Day 90 | Eyes | Eyes |
|
|
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| Secondary | Post op Pain Management Per Eye | Count of participants requiring pain management from Day 0 to Day 90. | Posted | Count of Units | Eyes | Day 0 to Day 90 | Eyes | Eyes |
|
|
|
| Secondary | Patient Preference Between Groups | As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. | All subjects were seen through week 1; three were lost to follow up thereafter. | Posted | Count of Participants | Participants | Day 7, Day 30 and Day 90 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Topical Prednisolone Acetate Ophthalmic Drops | Topical prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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| 1 month |
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| 3 months |
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| Day 30 |
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| Day 90 |
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